Stakeholders are confident that recommendations with examples of regular cost elements will help to more accurately determine the compensation associated with conducting a clinical trial. In addition, a common set of standard clauses for the establishment of contracts related to clinical trials will significantly speed up contract negotiations. This article provides an overview of the key points of the recommendations for the determination of total performance compensation and standard contractual clauses. What`s good – in an international comparison, Germany offers good basic prerequisites for clinical research: the conduct of clinical trials is often subject to a lot of time pressure and plays an important role in international competition, especially in the time before the start of a clinical trial. In order to start a clinical trial as soon as possible, it should be possible to negotiate contracts between the parties involved quickly, fairly and simply and in terms of content. Germany, as a clinical trial site, is currently well positioned and competitive internationally. This is reflected in the position of number two in Europe and number three worldwide – behind the United States and Great Britain – in clinical trials with drugs sponsored by pharmaceutical companies.1 Maintaining and further improving this favorable positioning as a place for clinical trials is in the mutual interest of all participants in the field of clinical research in Germany as well as patients, Study centers and clinical trial sponsors. For patients, clinical trials offer the opportunity to quickly access innovative treatment options. In addition to the scientific interest of medical schools, clinical research is an essential task of university hospitals in Germany in fulfilling their medical care mandate. Their participation in clinical trials gives physicians the opportunity to lay the groundwork for evidence-based decisions, gain early experience with new therapeutic approaches, and pass this know-how on to their patients.
The authors of these joint recommendations2 and the model contractual clauses3 share their interest in strengthening Germany`s international position as a clinical trial site and maintaining the high standards established in Germany. In this context, the German Association of Faculties of Medicine (MFT), the German Association of Academic Medical Centers (VUD), the Clinical Trials Coordination Center (KKS Network) and the Association of Research-Based Pharmaceutical Companies (vfa) held joint discussions on two important aspects related to clinical trials – contract negotiations and remuneration considerations for clinical trials. This model agreement for clinical trials was developed as part of a collaboration between vereniging Samenwerkende Topklinische opleidingsZiekenhuizen (STZ), Nefarma, Stichting Het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis (NKI/AvL) and ACRON to facilitate the conduct of clinical trials in the Netherlands. The termination and publication clauses are consistent with the CCMO`s Directive on Clinical Trial Agreements. The recommendations also ensure that double billing is avoided, as no additional remuneration would be paid for standard treatment activities that have already been reimbursed by German health insurance companies – even if the patient is enrolled in a clinical trial. In order to do so, it is necessary to determine in the investigator`s brochure which measures taken in the context of a clinical study are, according to the protocol, a necessary part of a patient`s standard treatment within the framework of the German health insurance funds. Similarly, the elements of the protocol that are specifically carried out in the context of the conduct of the clinical trial and its objectives must be specified. On that basis, the services provided by a testing body shall be remunerated by the sponsor, including all services directly related to the conduct of the clinical trial provided to or with the patient, such as. B, a consultation (patient information), blood samples, physical and instrumental diagnostics, an ECG, etc. and the preparation of the necessary documentation specific to the study (reports, B certificates). This may also include internal transportation costs for patients, by . B to diagnostic centres, yes.
B electronic radiological examinations are required. In addition to patient- and treatment-specific expenses, total indirect costs must also be taken into account. .
